Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training (CUT-IT)
3 de agosto de 2014 actualizado por: Eva Prescott
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training: A Randomized Clinical Trial
The purpose of the study is to make a head-to-head comparison of weight loss and interval training as methods of secondary prevention in overweight patients with ischemic heart disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI > 25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of cardiovascular disease and diabetes in these subjects. Additionally, a British study using a very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However, the effect of LED has never been examined in overweight patients with IHD.
Several studies have shown that patients with IHD have a beneficial effect of exercise training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group has shown that aerobic interval training results in the biggest increase in maximal oxygen uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD.
In conclusion, weight loss and exercise are known strategies in preventing progression of IHD and development of type 2 diabetes in these patients, however a head-to-head comparison of the two methods has never been made and it is unknown which intervention is the most effective in improving cardiovascular risk profile. Furthermore, several mechanisms behind the known beneficial effect of these interventions are unknown.
Tipo de estudio
Intervencionista
Inscripción (Actual)
70
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Copenhagen, Dinamarca, 2400
- Bispebjerg hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
45 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Stable Ischemic Heart Disease
- BMI 28 - 40 kg/m2
Exclusion criteria:
- Known Diabetes Mellitus
- Repeated Fasting plasma glucose ≥ 7 mmol/L or Hba1c > 7 %
- Severe or moderate valve disease
- Main stem stenosis
- Severe heart failure, Ejection Fraction < 35 %
- Physical or mental disability which are expected to prevent completion of intervention
- Severe Chronic obstructive Pulmonary Disease (COPD) (FEV1 < 50 % of expected) or asthma
- Active cancer
- Severe kidney (GFR < 40 ml/hour) or severe liver disease
- Severe ischemia or arrhythmias during exercise test
- 2. or 3. degree atrio-ventricular (AV) block, not protected by pacemaker
- Organised training more than 2 times a week prior to inclusion
- Significant weight loss or weight gain (> 5 %)3 month prior to inclusion
- Not able to comprehend written and oral informed consent
- Hormone treatment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Weight Loss
12 weeks of Low Calorie Diet to obtain a 10 - 15 % weight loss.
Followed by 40 weeks on a weight maintenance diet and interval training 2 times a week.
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Low calorie diet approx.
1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
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Experimental: Interval Training
12 weeks of interval training 3 times a week followed by 40 weeks of interval training 2 times a week.
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Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike.
Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate.
Active intervals are separated by active pauses at 60% of maximal heart rate.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Coronary Flow Reserve following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed by a non-invasive echocardiographic Doppler measurement
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0, 12 and 52 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Heart Rate Variability and silent ischemia following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed by Holter Monitoring for 24 - 48 hours
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0, 12 and 52 weeks
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Change in endothelial function following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Using the Endopat 2000 from Itamar
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0, 12 and 52 weeks
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Change in systolic and diastolic function following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed by echocardiography resting and during physiological and medical stress.
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0, 12 and 52 weeks
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Change in body composition following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed by anthropometry, dual X-ray absorptiometry (DXA) (lean body mass, percentage adipose tissue) and abdominal MRI (liver fat, muscle fat, subcutaneous fat and visceral fat at the level of L3).
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0, 12 and 52 weeks
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Change in myocardial blood flow following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed by positron emission tomography of the heart
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0, 12 and 52 weeks
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Change in insulin action, beta cell function and incretin secretion following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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A Oral Glucose Tolerance Test is performed.
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0, 12 and 52 weeks
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Change in oxidized lipids and lipoprotein particle size following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Change in peak oxygen uptake (VO2max) following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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Assessed using a bicycle ergometer
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0, 12 and 52 weeks
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Change in blood pressure following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Change in inflammatory markers in urin, blood and adipose tissue following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Change in quality of life following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Change in ceramides, diacylglycerol og endocannabinoid (CB)-1 receptors in adipose tissue following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Change in hormones derived from adipose tissue following the diet or training intervention and a maintenance period
Periodo de tiempo: 0, 12 and 52 weeks
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0, 12 and 52 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eva Prescott, MD, DMsc, Bispebjerg hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pedersen LR, Olsen RH, Frederiksen M, Astrup A, Chabanova E, Hasbak P, Holst JJ, Kjaer A, Newman JW, Walzem R, Wisloff U, Sajadieh A, Haugaard SB, Prescott E. Copenhagen study of overweight patients with coronary artery disease undergoing low energy diet or interval training: the randomized CUT-IT trial protocol. BMC Cardiovasc Disord. 2013 Nov 19;13:106. doi: 10.1186/1471-2261-13-106.
- Pedersen LR, Olsen RH, Jurs A, Astrup A, Chabanova E, Simonsen L, Wisloff U, Haugaard SB, Prescott E. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease: The CUT-IT trial. Eur J Prev Cardiol. 2015 Aug;22(8):1009-17. doi: 10.1177/2047487314545280. Epub 2014 Jul 31.
- Pedersen LR, Olsen RH, Anholm C, Astrup A, Eugen-Olsen J, Fenger M, Simonsen L, Walzem RL, Haugaard SB, Prescott E. Effects of 1 year of exercise training versus combined exercise training and weight loss on body composition, low-grade inflammation and lipids in overweight patients with coronary artery disease: a randomized trial. Cardiovasc Diabetol. 2019 Oct 1;18(1):127. doi: 10.1186/s12933-019-0934-x.
- Pedersen LR, Olsen RH, Anholm C, Walzem RL, Fenger M, Eugen-Olsen J, Haugaard SB, Prescott E. Weight loss is superior to exercise in improving the atherogenic lipid profile in a sedentary, overweight population with stable coronary artery disease: A randomized trial. Atherosclerosis. 2016 Mar;246:221-8. doi: 10.1016/j.atherosclerosis.2016.01.001. Epub 2016 Jan 13.
- Pedersen LR, Olsen RH, Jurs A, Anholm C, Fenger M, Haugaard SB, Prescott E. A randomized trial comparing the effect of weight loss and exercise training on insulin sensitivity and glucose metabolism in coronary artery disease. Metabolism. 2015 Oct;64(10):1298-307. doi: 10.1016/j.metabol.2015.07.007. Epub 2015 Jul 17.
- Olsen RH, Pedersen LR, Jurs A, Snoer M, Haugaard SB, Prescott E. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease. Int J Cardiol. 2015 Apr 15;185:229-35. doi: 10.1016/j.ijcard.2015.03.118. Epub 2015 Mar 11.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2011
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
7 de noviembre de 2012
Publicado por primera vez (Estimar)
12 de noviembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de agosto de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2014
Última verificación
1 de agosto de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CUT-IT
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